Keeping Track: US FDA Okays Alnylam’s siRNA Amvuttra, Alopecia Claim For Lilly’s Olumiant; Sierra Submits Momelotinib
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Keeping Track: Terliprez, Sotyktu Keep Up US FDA’s Novel Approvals Pace; Submissions By Pfizer, Chiesi And BioLineRx
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Concert’s Patient-Reported Outcome Could Help Differentiate Its Alopecia Therapy
Concert’s CTP-543 would be second or third to market in alopecia areata, behind Lilly and likely Pfizer, but the biotech thinks its drug will have the best profile based on efficacy and patient satisfaction.
Janssen’s Multiple Myeloma Drug Among 11 Products To Get EMA Thumbs Up
The European Medicines Agency has cleared the decks for the pan-EU approval of nearly a dozen new drugs. Tecvayli is headed for a conditional approval, while Nulibry is slated to get marketing authorization under exceptional circumstances.